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Depression And Bipolar Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Depression And Bipolar Disorder

A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Depression in Patients With Type II Bipolar Disorder

NCT00274677•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Inclusion
•Patients must provide written and informed consent.
•Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks.
•Exclusion
•Patients must not be suicidal.
•Patients must not have a history of non-response to antidepressant treatment.
•Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry.
•Patients must not have had epilepsy or hypothyroidism.

Locations (19)

GSK Investigational Site

Burbank, California, United States

GSK Investigational Site

Loma Linda, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Terre Haute, Indiana, United States

GSK Investigational Site

Shreveport, Louisiana, United States

GSK Investigational Site

Saint Charles, Missouri, United States

GSK Investigational Site

Clementon, New Jersey, United States

GSK Investigational Site

Princeton, New Jersey, United States

GSK Investigational Site

New York, New York, United States

Key Dates

Start Date

November 1, 2003

Primary Completion Date

August 1, 2005

Completion Date

August 1, 2005

Last Updated

September 15, 2016

Enrollment

221

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

Placebo

DRUG

lamotrigine

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Depression And Bipolar Disorder

Inclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

CBT-CP for Veterans With SMI

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Early Intervention for Youth at High Risk for Bipolar Disorder